FDA Extends Educational Period for New Policy on Compounding Animal Drugs from Bulk Drug Substances

October 4, 2022 — 

The Food and Drug Administration has delayed enforcement of its finalized guidance regarding compounding animal drugs from bulk drug substances until April 2023.

The Food and Drug Administration issued final guidance, unveiled in April, on the use of bulk drug substances for compounding animal medications. Under Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances, the FDA delineates the circumstances under which it will exercise enforcement discretion related to violations of the Federal Food, Drug, and Cosmetic Act for drug approval, labeling, and manufacturing when pharmacists and veterinarians compound drugs from bulk drug substances for animal patients.

The guidance does not touch on compounding under the FDA Extralabel Drug Use regulations, which apply when an FDA-approved drug or indexed drug is used as the starting material.

Read more at AVMA

[Source: AVMA ] 26 September 2022